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CommentaryDigital Health

Commentary: The FDA Just Approved the First Digital Pill. Here’s How It Could Backfire.

By
Peter D. Kramer
Peter D. Kramer
and
Bethany Cianciolo
Bethany Cianciolo
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By
Peter D. Kramer
Peter D. Kramer
and
Bethany Cianciolo
Bethany Cianciolo
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November 15, 2017, 10:25 AM ET
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Three years ago, I became involved in the care of a forgetful elderly relative who lived hours away and required twice-daily treatment with medications for chronic ailments. How useful it would have been for us if he had been able to use digital pills of the sort that the FDA has just approved—so far for a single drug, a treatment for psychosis called Abilify.

Here’s how the technology works: When you swallow the tablet, your stomach acid activates a sensor that signals a patch taped to the skin above your ribs. The patch relays the news to your mobile phone, which forwards it to anyone monitoring your care.

That technology will be welcome when it improves adherence to treatments for cancer or heart disease. Someday, we may all track our drug usage—and never fret over whether we remembered to take our Alzheimer’s preventative.

But for now, there’s something creepy about a nanny pill for mental illness.

With drugs for the brain, we worry immediately about Cuckoo’s-Nest-style coercion. Modern Nurse Ratcheds will know immediately whether their McMurphys have cheeked their pills. Once the technology is available, won’t courts use it? A judge will say, “Unless you comply with treatment, your probation will be revoked.” Fair enough, perhaps—but what if, in a divorce, the child visitation privileges are dependent on a parent’s documented adherence to a treatment regimen?

And what if the news collector is your boss? In Listening to Prozac, I speculated about social coercion. If a salesperson’s competitors are taking a drug that makes them quick and assertive, she may need to take it, too. With digital pills, seeking that leg up could become a (monitored) condition of employment. It’s a slippery slope, then, to a Brave New World scenario, with this fillip: The government has constant electronic confirmation that the low castes are taking their soma.

We may not need science fiction to explain our queasiness. The FDA-approved drug label notes that so far there is no evidence that digital pills make compliance likelier. Soon, someone will do a study and see. Perhaps, on tattletale pills, patients take medicines more reliably. But would that result answer the important question?

Imagine a paranoid man who takes digital Abilify, dislikes the experience, discontinues medication, and when the next episode of psychosis emerges, fails to seek help because he hated being spied on. Awareness of doctors’ capacity to monitor may discourage some people from seeking treatment in the first place.

Mentally ill patients want autonomy. The capacity to look in on daily behavior may complicate relationships between parents and their adult children with schizophrenia.

The truth is, as psychiatrists, we wish that this technology had been pioneered on treatments for other conditions. Tuberculosis is a good candidate. It’s crucial that infected patients take their antibiotics reliably. Intermittent usage can encourage the growth of drug-resistant strains of the bacillus.

It’s also true that, as a practicing doctor, I would value information about how patients use what I prescribe. When a depressed woman reports that her medication has stopped working, I would like to know that she has skipped more pills than she realizes. Then, I won’t be moved, say, to add a second antidepressant.

 

It’s easy to imagine instances when shared information leads to productive conversations between patients and providers or family members.

Certainly, outcome trials will be more reliable if researchers can be sure that participants have not simply tossed away the medicines being tested.

As with all new technologies, the eerie will quickly become the customary, and advantages and complexities will emerge with adoption in everyday life. But the creepiness we feel now is a signal worth acknowledging.

Applied to mental health care, the big-brother pill brings ethical concerns. While we monitor drug compliance, we’ll need to monitor those, too, in hopes that we can make the digital drug a source of liberation from illness and not cause of continued suffering or a new means of social control.

Peter D. Kramer is an emeritus clinical professor of psychiatry at Brown University and the author, most recently, of Ordinarily Well: The Case for Antidepressants.

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